TTUHSC Institutional Biohazards Committee Registration Application to use Biohazardous Materials
Instructions for Registration
This registration must be submitted to and approved by the Institutional Biohazards Committee prior to the reporting of
protocol approval by the HSC to granting agencies for protocols which utilize hazardous materials and animals and prior
to commencement of any experimentation using these registered materials.
WHAT TO REGISTER:
IBC protocol approval is required before purchasing, storing, or using:
 Highly toxic chemicals or biotoxins (LD50 (oral/rat) < 50 mg/kg).
 Any Biosafety Level-2 or above agents.
 “Select agents” in any amount (infectious agents and biotoxins listed in 42 CFR Part 73).
 Tissues (fixed or unfixed), fluids or cell lines derived from humans or non-human primates (human
and non-human primate materials are considered at BSL-2).
NOTE: Any use of Biosafety level 2 microbiological/infectious agents, human or non-human primate fluids (i.e., blood, serum, etc.)
tissues or cells (i.e., cell lines, including established, immortalized cell lines like HeLa and Hep-2), and highly hazardous chemicals
must be reviewed and approved by the Institutional Biohazards Committee before the procedure is initiated. A non-comprehensive
listing of biohazards or highly hazardous chemicals/toxins which MUST be registered are available at:
http://www.ttuhsc.edu/Admin/safety/lab/CHEMICALS_TOXINS_REQUIRING_IBC_REGISTRATION.pdf
http://www.ttuhsc.edu/Admin/safety/lab/BIOLOGICALS REQUIRING_IBC_REGISTRATION.pdf
HOW TO REGISTER:
Determine which Biosafety Level (BSL) the protocol calls for, and determine if safety equipment and facilities are
appropriate for procedures involving the chemicals or biotoxins, biological agents, and/or human or non-human primate
fluids, tissues or cells. Again, see the following form for specific requirements. For Biosafety questions please contact
the Lab Safety Division in Safety Services: Tel.: (806) 743-2597; FAX: (806) 743-1299 or Safety.Services@ttuhsc.edu.
For administrative questions please contact Lee Paradise in Sponsored Programs via e-mail or phone (806) 743-2960.
This completed form must be submitted (through e-mail) to Lee Paradise (Lee.Paradise@ttuhsc.edu), Office of
Sponsored Programs. Sponsored Programs will send notification upon approval of applications and amendments.
Upon approval by the Institutional Biohazards Committee, the completed IBC application, with addendums, must be
placed in the laboratory in the TTUHSC Laboratory Compliance Manual and be available to employees in the laboratory.
NOTE: Save a copy of the completed form for your records.
NOTE: Certification of laboratory safety training for laboratory personnel will be established by successfully
completing appropriate exam(s) approved by the Institutional Biohazards Committee, and will be so
stated on the Biohazards License.
COMMITTEE MEETING DATE:
The Committee typically meets the first Tuesday of each month. Registration materials must be received no later than
9:00 a.m. the Tuesday Two (2) Weeks preceding the meeting in order to ensure consideration at that month’s meeting.
Revisions of information concerning changes to personnel, materials, procedures or practices from your previous
registration must be submitted (through e-mail) to Lee Paradise, Office of Sponsored Programs at least Two (2) Weeks
preceding the IBC meeting and prior to implementing the change. Protocols will be reviewed on an annual basis. Entire
protocols must be resubmitted every third year.
This form must be typed
http://www.ttuhsc.edu/admin/safety
Texas Tech University Health Sciences Center
Institutional Biohazards Committee
Registration Application to use Biohazardous Materials
(Submit to Lee.Paradise@TTUHSC.edu no later than two (2) weeks prior to the first Tuesday of each month)
If assistance is needed in completing this form, please contact:
Lab Safety Division in Safety Services: Tel.: (806) 743-2597; FAX: (806) 743-1299 or Safety.Services@ttuhsc.edu
All of the Following Questions Must Be Answered for this Form to be Complete
(If Not Applicable Please Type N/A)
Project and Researcher Information
1. Is this Registration:
New or
Renewal? If renewal, Protocol Number
2. Materials being registered on this application:
3. Title and Brief Description of Projects registered on this application (Please number projects if more than one):
4. Principal Investigator:
5. Title:
6. Department:
7. Address (office):
8. Laboratory Room Number(s) where materials will be used: (Indicate usage areas with a “U”, storage areas with an “S” if
different than use areas, and shared locations “C” (i.e., inner lab, culture room, etc.)
9. Phone (Office):
(Laboratory):
10. FAX:
11. E-Mail:
12. Co-Investigator:
13. Title:
14. Department:
15. Staff Members included on this application (list all with titles):
16. Describe safety training received by above mentioned staff members:
17. Administrative Controls – Processes or procedures established by the Principal Investigator for the purpose of reducing personnel
exposure to highly hazardous chemicals and/or biological materials (aerosols, contamination, dusts, etc.). Indicate those that apply
to this project.
Ergonomic Design Layout
Access Restriction
Site Specific Training
Special Personal Hygiene Measures
Signs and Labels
Special Housekeeping Issues
Project Risk Assessment
Special Prohibited Activities
Other Appropriate Means to Promote Safe Operation.
Describe as necessary any of the above in the following text box:
18. Engineering Controls – While performing this procedure, the following safety equipment must be accessible and used: (e.g.,
chemical fume hood, biological safety cabinet, etc.):
19. Protective Equipment – Prior to performing this procedure, the following personal protective equipment must be obtained and
used: (e.g., gloves, eye protection, lab coats, etc.) Be specific.
20. Waste Disposal – This procedure will result in the following regulated waste that must be disposed of in compliance with federal
and state environmental regulations. Proper waste procedures consist of (e.g., decontamination of etiological wastes must occur
prior to removal from the laboratory):
http://www.ttuhsc.edu/admin/safety
21. Emergency Procedures – In the event of a highly hazardous chemicals and/or biological material spill during this procedure, loss
of utilities, or other emergency, be prepared to execute the following emergency shutdown or containment procedures: List
decontamination materials or spill kits and any other necessary supplies to be used. Include signs and symptoms of release, contact
and exposures (e.g., appearance, odor, irritation, etc.) Address realistic worst case occurrences.
Biohazardous Material(s) Relevant to this Application
22. Categories of Biohazardous Materials: (Check all that apply)
Biological Materials (Defined as all infectious organisms (bacteria, fungi, parasites, prions, rickettsiae, viruses) that can cause
disease in humans or cause significant environmental or agricultural impact, in addition to all human or non-human primate tissues,
fluids, and primary cell lines, all transgenic animals and plants, recombinant DNA, and all natural or genetically-engineered human
and animal cell lines that are pathogenic to humans) See list at:
http://www.ttuhsc.edu/Admin/safety/lab/BIOLOGICALS_REQUIRING_IBC_REGISTRATION.pdf
Bacteria (including Rickettsiae), viruses, fungi, parasites, and prions that are pathogenic to humans (BSL-2 or higher);
Human or non-Human Primate Fluids, Tissues, or Primary Cells;
Established Cell Lines requiring registration. NOTE: Registration is required for all human cell lines and any animal cell
lines that express human genes or substances pathogenic to humans. In general, other animal cell lines are exempt from registration.
Complete Addendum A (download extra copies if necessary)
Proposed Biosafety Level: 2 or
3
Highly Hazardous Chemicals & Toxicants (Defined as any chemical or toxin which is highly toxic, hazardous chemical = LD50
(oral/rat) of ≤50 mg/kg) See list at:
http://www.ttuhsc.edu/Admin/safety/lab/CHEMICALS_TOXINS_REQUIRING_IBC_REGISTRATION.pdf
Complete Addendum B (download extra copies if necessary)
Recombinant DNA Molecules
Complete Addendum A (download extra copies if necessary) for infectious organisms, expression of hazardous genes
or drug resistance trait(s). Also, complete and submit a registration application with the Recombinant DNA
Committee.
Radioactive Materials or Radiation Producing Devices
Complete and submit a registration application with the Radiation Safety Committee.
Register only with the Institutional Biohazards Committee if the chemical is also characterized as Highly Hazardous.
Human Gene Therapy
Complete and submit registration applications with both the Institutional Review Board and the Recombinant DNA
Committee.
Register only with the Institutional Biohazards Committee if transfer of human fluids, tissues or cells are involved.
Animals
Complete and submit a registration application with the Animal Care and Use Committee after IBC approval.
Also, complete the following when the project involves hazardous chemicals, toxins or infectious agents.
Species:
Location(s):
ACUC Protocol No (If known):
Risks to Personnel from Animal: Urine Feces Saliva Blood Bedding
Contact with lesions on Animals Penetrating Injury from Contaminated Cages
Mucus Membrane Contact with Secretions or Excretions Other (specify):
Aerosols
Animal Bites or Scratches
Check all that apply. If any are marked, explain risk and precautions necessary to prevent or reduce the
risks to personnel:
http://www.ttuhsc.edu/admin/safety